Our client, a medical device company in Galway is currently looking to recruit a Supplier Quality Engineer for their site.
The Supplier Quality Engineer will manage all purchasing and supplier quality related aspects of Galway QMS. This covers the management and, as required, the execution of supplier audits, non-conformance investigations, supplier monitoring and communication. Related duties will include validation studies, process improvement projects and project management.
- Manage all aspects of the Quality System with respect to purchasing & supplier quality, including procedures, risk assessments and Approved Vendor List
- Execute supplier audits as required.
- Manage Supplier Monitoring & Management process,
- Provide support to purchasing team in resolution of issues, non-conformances and CAPA’s
- Evaluate quality trends and reasons for process failures and lead corrective action plans
- Become an active member of the site internal audit team.
- Prepare and maintain supplier related documentation in compliance with the appropriate regulatory requirements.
- Support projects to identify and qualify new/ alternative suppliers
- Support continuous improvement activities
- Work and procurement to develop site strategy with respect to all quality aspects of supplier management.
- Review and Approval of supplier and purchasing Quality related documents.
- Generate Quality documentation (e.g. CO’s, Qi’s, CAPA’s, SCAR’s.).
- Manage the development of new suppliers.
- Bachelors Science degree (Engineering or Science) is required with 4 years minimum experience in the medical device required
- Effective communication and conflict resolution skills
- Effective problem-solving techniques (i.e. Root Cause Analysis, FMEA process, Validation activities, etc.)
- Conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to QI, CAPA’s and SCAR’s
- Thorough understanding of Risk Management principles
- Strong communication and organizational skills to effectively manage and get results with external suppliers
- Certified Quality Auditor
For further information on this Supplier Quality Engineer role in Galway please contact Alan Prendergast on 0860462367/ firstname.lastname@example.org
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